MCM Legal, Regulatory and Policy Framework
The FDA Medical Countermeasures Initiative (MCMi) legal, regulatory, and policy framework ensures that U.S. laws, regulations and policies help support preparedness and response for potential chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease threats. MCMi also helps facilitate advances in regulatory science available for practical use in the regulatory review process.
Information in this Section
MCM-Related Counterterrorism Legislation
Summary of federal legislation enacted to strengthen the nation's preparedness for responding to public health emergencies involving CBRN and emerging infectious disease threats
MCM-Related Legal and Policy Presentations, Publications and Q&As
Updates on FDA activities to support the MCM-related legal and policy framework, to better protect national health and security
MCM Emergency Use Authorities
FDA may need to use special authorities to allow the use of MCMs in impacted populations during or in anticipation of emergencies. More information about mechanisms FDA can use to allow the emergency use of MCMs.
Emergency Use Authorization
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies
- Unapproved uses of approved MCMs (Emergency Use of Approved MCMs)
PAHPRA establishes streamlined mechanisms to facilitate certain MCM preparedness and response activities without an EUA. Overview of new tools, which are applicable only to eligible FDA-approved medical products intended for use during a CBRN emergency.
Expiration Dating Extension
Information on various expiration dating extension activities, including the Shelf Life Extension Program (SLEP), emergency use authorities and enforcement discretion
State, Tribal, Local, and Territorial Public Health Preparedness
FDA works closely with stakeholders at the state and local levels to support public health preparedness and response efforts related to MCMs
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
PAHPRA contains key legal authorities to sustain and strengthen our nation's preparedness for public health emergencies involving CBRN agents, as well as emerging infectious disease threats
Guidances and Other Information of Special Interest to MCM Stakeholders
Guidance documents of special interest to existing or prospective MCM sponsors, and other stakeholders, including state, tribal, local and territorial public health preparedness personnel